Benactivdol Gola is indicated for the short-term symptomatic treatment of acute pain in sore throat in adults.
Active Ingredients
One spray contains 2.92 mg Flurbiprofen, three sprays equal to one dose contain 8.75 mg, corresponding to 16.2 mg/ml Flurbiprofen Excipients with known effect: Methyl parahydroxybenzoate (E218) 1.18 mg/dose Propyl parahydroxybenzoate (E216) 0.24 mg/dose Flavours containing allergens (mint flavour and cherry flavour) For the full list of excipients, see section 6.1.
Excipients
Betadex Sodium phosphate dibasic dodecahydrate Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Sodium hydroxide Mint flavour Cherry flavour N,2,3-Trimethyl-2-isopropylbutanamide Sodium saccharin (E954) Hydroxypropylbetadex Purified water Qualitative composition of the flavour Mint: Flavouring substances Flavouring preparation Propylene glycol E1520 Glyceryl triacetate (Triacetin) E1518 Qualitative composition of the flavour Cherry: Flavouring substances Flavouring preparation Propylene glycol E1520 Water
Dosage
Posology For short-term treatment only. Indicated for adults over 18 years of age: One dose (3 sprays) directed at the affected part of the throat every 3-6 hours as needed, up to a maximum of 5 doses in a 24-hour period. Paediatric population The safety and efficacy of Benactivdol Gola in children or adolescents under 18 years of age have not been established. Elderly population A general dosage recommendation cannot be given, as clinical experience to date is limited. Elderly people are at increased risk of serious consequences in case of adverse reactions. The lowest effective dose should be administered for the shortest duration possible to control symptoms (see section 4.4). Method of administration For oromucosal administration Do not inhale during spraying. This medicinal product should not be used for more than 3 days. Before use, it is necessary to operate the pump 4 times, pointing the dispenser away from your body, until a uniform and consistent mist is released. The pump is then ready for use. Between one use and the next, dispense a minimum amount of product, away from your body, in order to ensure that the mist is uniform and consistent. Before using the product, always ensure that the mist is uniform and consistent.
Warnings
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Infections Since isolated cases of exacerbation of infection-related inflammation (e.g. development of necrotizing fasciitis) have been reported in temporal association with the systemic use of drugs belonging to the class of NSAIDs, patients are advised to consult a doctor immediately if signs of a bacterial infection appear or worsen during therapy with flurbiprofen spray. The indication for initiation of antibiotic therapy should be considered. In case of purulent bacterial pharyngitis/tonsillitis, the patient should consult a doctor for a review of the treatment. Treatment should not be administered for more than 3 days. Treatment should be re-evaluated if symptoms worsen or new symptoms appear. If mouth irritation develops, treatment with flurbiprofen should be discontinued. Elderly population The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Respiratory disorders Bronchospasm may be precipitated in patients suffering from or with a history of bronchial asthma or allergic disease. Flurbiprofen spray should be used with caution in these patients. Other NSAIDs The use of flurbiprofen spray should be avoided in conjunction with other NSAIDs, including cyclooxygenase-2 selective inhibitors (see section 4.5). Systemic lupus erythematosus (SLE) and mixed connective tissue disease Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease may be at increased risk of aseptic meningitis (see section 4.8), however this effect is not usually seen with products intended for short-term use such as flurbiprofen spray. Cardiovascular, renal and hepatic impairment NSAIDs have been reported to cause various forms of nephrotoxicity, including interstitial nephritis, nephrotic syndrome and renal failure. Administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of developing this reaction are those with impaired renal function, cardiac impairment, hepatic dysfunction, those on diuretic therapy and the elderly; this effect is not usually seen with products intended for short-term use such as flurbiprofen spray. Hepatic effects Mild to moderate hepatic dysfunction (see sections 4.3 and 4.8). Cardiovascular and cerebrovascular effects Caution is advised before starting treatment in patients with a history of hypertension and/or heart failure (consult your doctor or pharmacist) since fluid retention, hypertension and edema have been reported in association with NSAID treatment. Data from clinical and epidemiological studies suggest that the use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increase in the risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk with flurbiprofen when administered at a daily dosage less than 5 times (3 actuations for each dose). Effects on the central nervous system Analgesic-induced headache - Headache may occur in case of prolonged or irregular use of analgesics, which should not be treated by increasing the dose of the drug. Gastrointestinal disorders NSAIDs should be given with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a history of serious GI events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3) and in the elderly; this effect is not usually seen with products intended for short-term use such as flurbiprofen spray. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to their doctor. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be discontinued. Haematological effects Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients with potential bleeding abnormalities. Dermatological effects Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Flurbiprofen spray should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. This product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (sometimes delayed). This medicinal product contains flavourings containing citral, d-limonene, eugenol and linalool. Citral, d-limonene, eugenol and linalool may cause allergic reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
